Sept. 30, 2024 – A newly FDA-approved drug will improve the diagnosis of coronary artery disease, the most common type of heart disease, which impacts more than 18 million adults in the U.S. and is the leading cause of death nationwide.
Given as a shot before heart imaging tests, the drug – called flurpiridaz and marketed under the brand name Flyrcado – is a radiotracer, a substance that helps doctors see inside the body during a scan. The approval was made using the agency’s priority review process, reserved for drugs that address serious conditions and work significantly better than existing options.
The current standard for examining blood flow through the heart and evaluating suspected coronary artery disease (CAD) is myocardial perfusion imaging with single photon emission computed tomography. It’s also known as a nuclear stress test.
With Flyrcado, the test can now be done using a PET scan – known to be better at detecting CAD, but not widely used because of challenges posed by other radiotracers.
“Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades,” Jamshid Maddahi, MD, the lead researcher for the Flyrcado clinical trials and a clinical professor at the UCLA School of Medicine, said in a news release from GE HealthCare, the drug’s maker. “I am excited for this new radiotracer and its potential impact, as a game changer, for diagnosing the disease with the highest mortality rate in the world.”
While other radiotracers must be produced on-site where the tests happen, Flyrcado can be made off-site and arrive at test locations ready to use. It lasts at least 109 minutes, potentially allowing for more testing in one session as well as time for repeat testing, if needed.
An estimated 6 million people get imaging for suspected CAD each year, according to GE HealthCare. Coronary artery disease is usually caused by a problem called atherosclerosis, which happens when plaque from fat and cholesterol builds up in the arteries and blocks blood flow. People with CAD may have chest pain or shortness of breath, and a complete blockage can cause a heart attack.
Flyrcado’s approval is based on the results of two studies, showing the drug helped identify 63% to 89% of those with CAD. One study suggested that the use of Flyrcado with PET myocardial perfusion imaging was particularly effective at detecting disease in women and in people who have obesity.
At least 2% of study participants who took Flyrcado had an adverse reaction such as shortness of breath, headache, chest pain that was sometimes severe, fatigue, flushing, nausea, belly pain, dizziness, and irregular heartbeat.
Flyrcado will be available starting in early 2025, according to GE HealthCare.
